2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC799
Submitter : Mrs. wendy norris Date & Time: 10/13/2005 08:10:17
Organization : Mrs. wendy norris
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
No- Why encourage the absolute disregard for life. This would only encourage teenage sexual activity because they will think they have any easy our for irresponsible behavior. Who are we to say as humans who has the right to live or die. That one unborn spirit may be the nest great person to do something in this world to improve it.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
no
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no
C. If so, would a rulemaking on this issue help dispet that confusion?
no
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
no
B. If it could, would it be able to do so as practical matter and, if so, how?
no
GENERAL
GENERAL
This product should not be approved. This is a moral issue and why should we as a society encourage pre-marital sex with the illusion that there is any easy way to to end an innocent life. This product kills children who were meant to be born on this earth. Every unborn child should be allowed a chance to survive.There are millions of people who would do anything to have a child. We are not God. We should not determine who lives or dies. Teenagers are not emotionally mature enough to understand the impact a decision such as this will have on their life.